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2009 Web Seminar Series Resolutions for Unexpected Site Challenges An Introduction to Risk Management 2009 Web Seminar Series Resolutions for Unexpected Site Challenges An Introduction to Risk Management Instructors: Charlotte Royer-Malvestuto, M. Ed. , MBE Jack Chally, M. B. A. "This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, Under Contract No. HHSN 271200522081 C. "

Training Outline n Introduce Risk Management ¨ Risk management recognizes and addresses unexpected site Training Outline n Introduce Risk Management ¨ Risk management recognizes and addresses unexpected site challenges in a proactive manner ¨ Potential threats are embraced and addressed instead of ignored or hidden n Case Study and Group Discussion ¨ Process helps identify critical components for continual, successful operations and the likelihood of disruption and appropriate plan to mitigate undesirable events 2

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Risk Management n Risk ¨A probability that some adverse circumstance will occur n Risk Risk Management n Risk ¨A probability that some adverse circumstance will occur n Risk Management ¨ Process for risk identification and contingency plan development to address risks n n n Done with each study section or overall Assess probability of occurrence (80%) Strategy or contingency plan for each risk 4

Risk Management Process n Risk Management Process ¨ Risk identification n ¨ Risk Assessment/Analysis Risk Management Process n Risk Management Process ¨ Risk identification n ¨ Risk Assessment/Analysis n ¨ Assess likelihood and consequences Risk Planning n ¨ Identify project, product and risks level Develop plans to avoid or minimise risk impact Risk Monitoring/Controlling n Monitor and adjust plans Risk Identification • Brainstorm to identify potential problems Risk Assessment • • Assess risk Severity Likelihood Controllability Risk Response Development • Plan to reduce possible damage • Make contingency plans Risk Monitor/Control • Implement risk strategy • Monitor and adjust • Change management 5

Revealing & Planning for Vulnerable Operations n n Generate list of possible risks Goal Revealing & Planning for Vulnerable Operations n n Generate list of possible risks Goal = Find potential problems before they happen Break into task areas ¨ Brainstorm ¨ Past experience ¨ n Focus on events that could create unwanted outcome Events Shipping delays Outcomes Failure to meet schedule Toy on stairs Staff member breaks leg Snow storm Opened late 6

Revealing & Planning for Vulnerable Operations Risk Log Risk Event Outcome Impact Likelihood Staff Revealing & Planning for Vulnerable Operations Risk Log Risk Event Outcome Impact Likelihood Staff turnover CTP Buy-in Miscommunication Informed Consent Errors 1 Minor Risk 2 3 Moderate Risk 4 5 Major Risk 7

Risk Assessment Process Risk Log Driving to Work in the Rain Risk Event Stuck Risk Assessment Process Risk Log Driving to Work in the Rain Risk Event Stuck in traffic Outcome Impact Likelihood Missed client meeting 4 4 1 Minor Risk 2 3 Moderate Risk 4 5 Major Risk 8

Risk Assessment Process Risk Severity Matrix Driving to Work in the Rain Likelihood 5 Risk Assessment Process Risk Severity Matrix Driving to Work in the Rain Likelihood 5 4 3 2 1 1 2 3 Impact 4 5 Minor Risk Moderate Risk Major Risk 9

Risk Assessment Process Risk Response Matrix Driving to Work in the Rain Risk Event Risk Assessment Process Risk Response Matrix Driving to Work in the Rain Risk Event Stuck in traffic Response to Risk Reduce, Share, Transfer or Accept risk Contingency Plan Leave 30 minutes early Trigger Weather report Person Responsible Jack 10

Risk Assessment & Management CASE STUDY Jane, a new RA, is conducting all scheduled Risk Assessment & Management CASE STUDY Jane, a new RA, is conducting all scheduled study visits but is often unable to complete and enter the CRFs within the required timeframe. It is becoming increasingly difficult to remember visit specifics and she is concerned about the quality of the data. Risk Log Risk Event Lag in CRF Completion Outcome Missed data/increased data queries Impact Likelihood 4 4 1 Minor Risk 2 3 Moderate Risk 4 5 Major Risk 11

Risk Assessment & Management Case Study Risk Severity Matrix Likelihood 5 4 3 2 Risk Assessment & Management Case Study Risk Severity Matrix Likelihood 5 4 3 2 1 1 2 3 Impact 4 5 Minor Risk Moderate Risk Major Risk 12

Risk Assessment & Management Case Study Risk Response Matrix Risk Event Response to Risk Risk Assessment & Management Case Study Risk Response Matrix Risk Event Response to Risk Lag in CRF Completion Reduce, Share, Transfer or Accept risk Contingency Plan Training Time Management /Cross-train Trigger QA visit/Data Queries Person Responsible Project Manager 13

Group Discussion Risk Assessment and Management Process 14 Group Discussion Risk Assessment and Management Process 14

Group Discussion Risk Log Risk Event Outcome Impact 1 Minor Risk Likelihood 2 3 Group Discussion Risk Log Risk Event Outcome Impact 1 Minor Risk Likelihood 2 3 Moderate Risk 4 5 Major Risk 15

Group Discussion Risk Severity Matrix Likelihood 5 4 3 2 1 1 2 3 Group Discussion Risk Severity Matrix Likelihood 5 4 3 2 1 1 2 3 Impact 4 5 Minor Risk Moderate Risk Major Risk 16

Group Discussion Risk Response Matrix Risk Event Response to Risk Contingency Trigger Person Plan Group Discussion Risk Response Matrix Risk Event Response to Risk Contingency Trigger Person Plan Responsible Reduce, Share, Transfer or Accept risk 17

Summary n Risk Assessment Process ¨ Reveals critical tasks in operations ¨ Possibilities for Summary n Risk Assessment Process ¨ Reveals critical tasks in operations ¨ Possibilities for disruption n Likelihood and impact rating ¨ Appropriate n response strategy Tools ¨ Risk event log ¨ Risk Severity Matrix ¨ Risk Response Matrix 18